NCT03338608

Platysma Incision Cosmesis

Influence of Platysmal Incision on Cosmetic Satisfaction Outcomes in Anterior Cervical Spine Surgery Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The anterior cervical fusion and decompression (ACDF) surgery provides direct access to symptomatic areas of the cervical spine. Cosmesis, including factors like wound healing, is an important issue for patients who undergo surgery on anterior neck structures. One significant factor that impacts cosmetic healing in patients who undergo the ACDF surgery is whether a vertical or transverse incision of the platysma muscle in the neck was used to access the cervical spine. The purpose of the present study is to compare cosmetic outcomes in vertical versus transverse platysmal incisions for anterior cervical spine exposures. Researchers intend to analyze this effect with a prospective comparative study model. A targeted number of 100 patients who undergo anterior cervical surgery, as part of their standard of care, will be randomized to receive either a transverse or vertical platysmal incision during the exposure part of their procedure. Informed consent for inclusion in the study, as approved by the Institutional Review Board, will be obtained from all patients in addition to consent for the surgical procedure. Regardless of the platysmal incision, all patients will receive a standard transverse skin incision, as is done routinely in anterior cervical exposures. After the surgery, all closures will be done in a standard manner. These patients will be followed up in the clinic at two weeks, three months, six months, and one year. They will be evaluated for wound healing and incision cosmesis using a modification of The Hollander Wound Evaluation Scale. Clinical photographs of the patients' necks will be captured during these visits in a manner that does not reveal any patient identifiers in any way. The incisions and overall cosmesis will be graded using the scale mentioned above. The data will be analyzed to determine if a transverse platysmal incision offers better cosmetic results than a vertical platysmal incision, or vice versa, and will also be used to validate the modified wound evaluation scale.

Conditions

• Wound Heal

Interventions

Type	Name	Description
PROCEDURE	Anterior Cervical Decompression and Fusion	Patients will receive the anterior cervical decompression and fusion as part of their standard of care. They will be randomized to either receive the vertical or transverse platysma incision.
PROCEDURE	Vertical Platysma Incision	A vertical platysma Incision will be used for the anterior cervical decompression and fusion surgical procedure
PROCEDURE	Transverse Platysma Incision	A transverse platysma incision will be used for the anterior cervical decompression and fusion surgical procedure

Timeline

• Start date: 2018-11-26
• Primary completion: 2019-09-15
• Completion: 2019-09-15
• First posted: 2017-11-09
• Last updated: 2020-07-07

Locations

1 site across 1 country: United States